18 results found
Ravikumar R, Lane TRA, Babber A, et al., 2021, A randomised controlled trial of neuromuscular stimulation in non-operative venous disease improves clinical and symptomatic status, Phlebology, Vol: 36, Pages: 290-302, ISSN: 0268-3555
BackgroundThis randomised controlled trial investigates the dosing effect of neuromuscular electrical stimulation (NMES) in patients with chronic venous disease (CVD).MethodsSeventy-six patients with CEAP C3-C5 were randomised to Group A (no NMES), B (30 minutes of NMES daily) or C (60 minutes of NMES daily). Primary outcome was percentage change in Femoral Vein Time Averaged Mean Velocity (TAMV) at 6 weeks. Clinical severity scores, disease-specific and generic quality of life (QoL) were assessed.ResultsSeventy-six patients were recruited - mean age 60.8 (SD14.4) and 47:29 male. Six patients lost to follow-up. Percentage change in TAMV (p<0.001) was significantly increased in Groups B and C. Aberdeen Varicose Veins Questionnaire Score (-6.9, p=0.029) and Venous Clinical Severity Score (-4, p-0.003) improved in Group C, and worsened in Group A (+1, p=0.025).ConclusionsDaily NMES usage increases flow parameters, with twice daily usage improving QoL and clinical severity at 6 weeks in CVD patients.
Babber A, Ravikumar R, Onida S, et al., 2020, Effect of footplate neuromuscular electrical stimulation on functional and quality‐of‐life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial, British Journal of Surgery, Vol: 107, Pages: 355-363, ISSN: 0007-1323
BackgroundSupervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof‐of‐concept study and RCT were conducted.MethodsIn study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five‐level instrument (EQ‐5D‐5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30‐min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements.ResultsStudy 1 (20 patients) showed a significant improvement in MCD (46 per cent; P < 0·001) and ICD (71 per cent; P < 0·001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46 per cent; P = 0·014). Improvements were seen in the ICQ (9 points; P = 0·009) and EQ‐5D‐5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031). Blood volume flow and time‐adjusted mean velocity increased significantly with the device on (P < 0·050). Overall, NMES compliance exceeded 95 per cent.ConclusionFootplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an ad
Lawton R, Babber A, Braithwaite B, et al., 2019, A multicenter randomized controlled study to evaluate whether neuromuscular electrical stimulation improves the absolute walking distance in patients with intermittent claudication compared with best available treatment, Journal of Vascular Surgery, Vol: 69, Pages: 1567-1573, ISSN: 0741-5214
Objective:To assess the clinical efficacy of an NMES device to improve the absolute walking distance (AWD) in patients with IC, as an adjunct to the local standard care available at the study sites compared to local standard care alone.Methods:An open, multicentre, randomised controlled trial including eight participating centres in England. Sites are equally distributed between those that provide SET programmes and those that do not. Patients with IC meeting the inclusion and exclusion criteria, and providing consent will be randomised, depending on the centre type, to either NMES and locally available standard care or standard care alone. The primary endpoint, AWD, will be measured at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life assessment, compliance with the interventions, economic evaluation of the NMES device, and lower limb haemodynamic measures to further the understanding of underlying mechanisms. Recruitment is due to commence in February 2018 and will continue for a total of 15 months. The NESIC trial is funded by the UK Efficacy and Mechanism Evaluation (EME) Programme, Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. ISRCTN 18242823.
Benaragama KS, Barwell J, Lord C, et al., 2018, Post-operative arterio-venous fistula blood flow influences primary and secondary patency following access surgery, Journal of Renal Care, Vol: 44, Pages: 134-141, ISSN: 1755-6686
PurposePrimary arteriovenous fistula arterio venous fistula (AVF) formation has proven to be the best and optimal vascular access for the majority of haemodialysis patients. At present there are limited data to suggest which haemodynamic parameters most correlate with the likelihood of early failure. The aim of this study is to identify the haemodynamic predictors of early failure, hence identify which fistulae may benefit from timely pre‐emptive intervention.Material and MethodsRetrospective analysis of data was performed of 201 patients undergoing native AVF creation over a one year period. Demographic details, co‐morbidity, preoperative vessel calibre were collected. Flow was measured by duplex ultrasound post operatively.ResultsPreoperative vein calibre (p = 0.01) and fistula flow (p < 0.001) positively affected primary patency. Age, gender, ethnicity, type of fistula, hypertension and preoperative arterial calibre did not influence outcome. Regression analysis showed that the strength of correlation between early postoperative fistula flow and patency decreased progressively with time. Six week flow predicts early, but not late, failure. ROC analysis identified 300 ml/min flow as the best predictor of patency. Fistulae with flow above 300 ml/min were more likely to remain patent over the next 12 months (p < 0.001, HR = 7.4).ConclusionPostoperative fistula flow of less than 300 ml/min identifies AVFs at high risk of early failure. These may be candidates for early intervention with balloon assisted maturation. The findings of this retrospective cohort study strongly support the need for a more robust prospectively designed trial identifying haemodynamic factors that can predict mid and long‐term AVF patency.
Ravikumar R, Williams KJ, Babber A, et al., 2018, Neuromuscular electrical stimulation (NMES) for the prevention of venous thromboembolism (VTE), Phlebology, Vol: 33, Pages: 367-378, ISSN: 0268-3555
ObjectiveVenous thromboembolism (VTE), encompassing deep vein thrombosis (DVT) and pulmonary embolism (PE), is a significant cause of morbidity and mortality, affecting 1 in 1000 adults per year. Neuromuscular electrical stimulation (NMES) is the transcutaneous application of electrical impulses to elicit muscle contraction, preventing venous stasis. This review aims to investigate the evidence underlying the use of NMES in thromboprophylaxis.MethodsThe Medline and Embase databases were systematically searched, adhering to PRISMA guidelines, for articles relating to electrical stimulation and thromboprophylaxis. Articles were screened according to a priori inclusion and exclusion criteria.ResultsThe search strategy identified 10 randomised controlled trials, which were used in three separate meta-analyses; 5 trials compared NMES to control, favouring NMES (odds ratio (OR) of DVT 0.29, 95%CI 0.13-0.65; P=.003); 3 trials compared NMES to heparin, favouring heparin (OR of DVT 2.00, 95%CI 1.13-3.52; P=.02); 3 trials compared NMES as an adjunct to heparin versus heparin only, demonstrating no significant difference (OR of DVT 0.33, 95%CI 0.10-1.14; P=.08).ConclusionNMES significantly reduces the risk of deep vein thrombosis compared to no prophylaxis. It is inferior to heparin in preventing DVT and there is no evidence for its use as an adjunct to heparin.
Ravikumar R, Williams KJ, Babber A, et al., 2016, Randomised Controlled Trial: Potential Benefit of a Footplate Neuromuscular Electrical Stimulation Device in Patients with Chronic Venous Disease, EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, Vol: 53, Pages: 114-121, ISSN: 1078-5884
Williams KJ, Babber A, Ravikumar R, et al., 2016, Non-invasive management of peripheral arterial disease., Advances in Experimental Medicine and Biology, Vol: 906, Pages: 387-406, ISSN: 0065-2598
BACKGROUND: Peripheral arterial disease (PAD) is common and symptoms can be debilitating and lethal. Risk management, exercise, radiological and surgical intervention are all valuable therapies, but morbidity and mortality rates from this disease are increasing. Circulatory enhancement can be achieved using simple medical electronic devices, with claims of minimal adverse side effects. The evidence for these is variable, prompting a review of the available literature. METHODS: Embase and Medline were interrogated for full text articles in humans and written in English. Any external medical devices used in the management of peripheral arterial disease were included if they had objective outcome data. RESULTS: Thirty-one papers met inclusion criteria, but protocols were heterogenous. The medical devices reported were intermittent pneumatic compression (IPC), electronic nerve (NMES) or muscle stimulators (EMS), and galvanic electrical dressings. In patients with intermittent claudication, IPC devices increase popliteal artery velocity (49-70 %) and flow (49-84 %). Gastrocnemius EMS increased superficial femoral artery flow by 140 %. Over 4.5-6 months IPC increased intermittent claudication distance (ICD) (97-150 %) and absolute walking distance (AWD) (84-112 %), with an associated increase in quality of life. NMES of the calf increased ICD and AWD by 82 % and 61-150 % at 4 weeks, and 26 % and 34 % at 8 weeks. In patients with critical limb ischaemia IPC reduced rest pain in 40-100 % and was associated with ulcer healing rates of 26 %. IPC had an early limb salvage rate of 58-83 % at 1-3 months, and 58-94 % at 1.5-3.5 years. No studies have reported the use of EMS or NMES in the management of CLI. CONCLUSION: There is evidence to support the use of IPC in the management of claudication and CLI. There is a building body of literature to support the use of electrical stimulators in PAD, but this is low
Williams KJ, Ravikumar R, Gaweesh AS, et al., 2016, A Review of the Evidence to Support Neuromuscular Electrical Stimulation in the Prevention and Management of Venous Disease, Advances in Experimental Medicine and Biology, Vol: 906, Pages: 377-386, ISSN: 0065-2598
INTRODUCTION: The prevention and management of venous disease is a therapeutic challenge. Movement of blood through the venous system is augmented by the action of muscles on the deep veins, and can be achieved through the application of electrical current. The efficacy of currently available clinical devices for this purpose is unknown, and is investigated here. METHODS: A literature search of the EMBASE and Medline databases was performed, and studies were included if they were full text articles, written in english, pertaining to venous disease and neuromuscular electrical stimulation (NMES). RESULTS: NMES devices increase venous haemodynamic parameters such as peak velocity and volume flow. Studies report them to be non-inferior to intermittent pneumatic compression. They are effective in the prevention of venous thromboembolism, though inferior to low molecular weight heparin. NMES can reduce symptoms of chronic venous disease. DISCUSSION: NMES is an important tool in the prevention and management of venous disease, and avoids the significant risks associated with heparin administration. Data explored here is heterogenous in device, protocol, and reported end-points, therefore should be interpreted with care. Long term effects of treatment with NMES have not been explored.
Ravikumar R, Williams K, Babber A, et al., 2016, A Pilot RCT: Neuromuscular Electrical Stimulation in Venous Disease, Vascular-Societies Annual Scientific Meeting, Publisher: Wiley, Pages: 21-21, ISSN: 1365-2168
Ravikumar R, Williams KJ, Babber A, et al., 2016, Neuromuscular Electrical Stimulation For Venous Thromboprophylaxis, Vascular-Societies Annual Scientific Meeting, Publisher: WILEY-BLACKWELL, Pages: 21-21, ISSN: 0007-1323
Babber A, Ravikumar R, Williams K, et al., 2016, Neuromuscular Electrical Stimulation in the Management of Intermittent Claudication: A "Stimulating" Prospect, Vascular Annual Meeting of the Society-for-Vascular-Surgery, Publisher: Elsevier, Pages: 16S-17S, ISSN: 1097-6809
Williams KJ, Babber A, Ravikumar R, et al., 2016, Non-Invasive Management of Peripheral Arterial Disease, Advances in Internal Medicine, Publisher: Springer International Publishing
Babber A, Dsa L, Ge Y, et al., 2015, Availability of supervised exercise programmes for patients with peripheral arterial disease, Annual Meeting of the Society-of-Academic-and-Research-Surgery (SARS(, Publisher: WILEY-BLACKWELL, Pages: 46-46, ISSN: 0007-1323
Babber A, Dsa L, Ge Y, et al., 2015, Outcomes of a supervised exercise programme for patients with intermittent claudication, Annual Meeting of the Society-of-Academic-and-Research-Surgery (SARS(, Publisher: WILEY-BLACKWELL, Pages: 48-48, ISSN: 0007-1323
Williams KJ, Ravikumar R, Babber A, et al., 2015, Can neuromuscular stimulation relieve symptoms of chronic venous disease, and improve quality of life?, Annual Meeting of the Society-of-Academic-and-Research-Surgery (SARS(, Publisher: WILEY-BLACKWELL, Pages: 9-9, ISSN: 0007-1323
Ravikumar R, Williams KJ, Babber A, et al., 2015, Electrical stimulation of the foot pump: a pilot randomised control trial in patients with chronic venous insufficiency, Annual Meeting of the Society-of-Academic-and-Research-Surgery (SARS(, Publisher: WILEY-BLACKWELL, Pages: 6-6, ISSN: 0007-1323
Babber A, Conlon T, Saeb-Parsy K, et al., 2011, Recognition of Graft Determinants Enables Direct, but Not Indirect, Pathway CD4 T Cells To Mediate Allograft Rejection Autonomously, American Transplant Congress, Publisher: WILEY-BLACKWELL, Pages: 82-82, ISSN: 1600-6135
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